MAUDE Adverse Event Report: QUEST MEDICAL INC MPS 3 CONSOLE; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Model Number 5301000

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 06/06/2022

Event Type  malfunction  

Event Description

While our cardiac perfusionist was using the 'quest medical mps 3' during a procedure, the 'bubble trap' portion of the device repeatedly failed, stating that there was air in the line when there wasn't, causing there to be a delay in care to the patient.When this device detects air in the system, it diverts the blood that is infused with potassium and lidocaine and recirculates it back through the machine instead of back through the patient.This process normally takes between 1 to 2 seconds, but in this instance the machine was constantly stating that there was air in the lines when there were no obvious signs of air.With the machine incorrectly saying that there was air in the line, it constantly kept the line open that recycles the blood and medication back into the machine instead of giving it back to the patient.The alarm would not clear, even with there being no air in any lines, so the line that was open because of the false alarm had to be clamped shut to make the pump work properly.The case was finished, and the machine was taken out of service.Manufacturer response for heat-exchanger, cardiopulmonary bypass, mps 3 console (per site reporter) our bio med department has been having trouble, until recently, contacting the reps and having this issue dealt with.They told us they would replace all 3 of our machines free of charge and get us brand new machines.

• Brand Name: MPS 3 CONSOLE
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): QUEST MEDICAL INC; 1 allentown pkwy; allen TX 75002
• MDR Report Key: 14674124
• MDR Text Key: 293834661
• Report Number: 14674124
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2022,06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5301000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Female
• Patient Weight: 86 KG